# K974164: Swiss Lithoclast Master Handpiece and 3.2 MM Probe

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Consultants, Inc.
- Decided: Dec 18, 1997 after 43 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K863642 (1986). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951531: Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1995) Summary page 2.
- K963285: Ems Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1997) Summary page 2.

## Most influential descendants
- K062475: Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM (2007), 1 descendant of its own
- K123038: Swiss Lithobreaker (2013), 0 descendants of its own

## Indications for use
The Swiss LITHOCLAST® MASTER HANDPIECE and the 3.2 MM PROBE are intended to be used as accessories to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm Probe is specifically indicated for use in fragmenting large stones in the bladder and kidney.

Source page: https://510kreport.com/device/K974164
Methodology: https://510kreport.com/methodology